Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars

Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars: A Randomized Controlled Clinical Trial

The aim of this study is to compare the clinical retention rates, marginal adaptation, marginal discoloration and secondary caries formation of two different types of resin-modified glass ionomers (Fuji® II LC; Clinpro™ XT Varnish) and giomer-containing fissure sealant materials (Beautifil Flow) with glass ionomer-containing fissure sealant material (Fuji Triage®) used on newly erupted non-carious first permanent molars as a fissure sealant.

The study included 384 teeth belonging to 182 children, aged between 5 to 9 years old, who have two newly erupted mandibular permanent first molars.

Study Overview

• Status: Completed
• Conditions: Fissure Sealant
• Intervention / Treatment: Device: Fuji® II LC CAPSULE; Device: Fuji Triage® CAPSULE; Device: Clinpro™ XT Varnish; Device: Beautifil Flow

Detailed Description

Firstly, patients were randomly allocated to three main groups: Group 1; Fuji II LC/Fuji Triage (Control) (62 patients), Group 2; Clinpro XT Varnish/Fuji Triage (Control) (60 patients), Group 3; Beautifil Flow/Fuji Triage (Control) (60 patients). After clinical applications, all samples were evaluated in terms of retention, marginal adaptation, marginal discoloration and secondary caries formation using modified USPHS criteria in 6th, 12th and 18th months. Also samples were evaluated in terms of remineralization effect using the laser fluorescence method. Evaluations on occlusal and buccal surfaces were performed separately.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Izmir Katip Celebi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children who have two newly erupted non-carious mandibular permanent first molars that fissure sealant is indicated,
• Newly erupted first permanent molars show scores of 0 (Sound tooth surface)-1(First visual change in enamel) according to ICDAS II,
• Newly erupted first permanent molars show scores between 0-13 by using DIAGNOdent device,
• Children who haven't any systemic disease that prevents the application,
• Cooperative children who allowed the clinical applications.

Exclusion Criteria:

• Teeth with proximal and initial caries,
• Teeth with applied fissure sealant,
• Teeth with developmental defects such as hypoplasia and restorations,
• Non-cooperative children who don't allow the clinical applications,
• Children and parents who denied the participation in the follow-up appointments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Fuji II LC-Fuji Triage); In Group 1, newly erupted mandibular permanent first molars were sealed with resin-modified glass ionomers containing fissure sealant material (Fuji® II LC, GC Corporation, Tokyo, Japan) (test 1). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control).	Device: Fuji® II LC CAPSULE; Fuji® II LC is a resin modified glass ionomer contained, fluoride releasing and light-cured material. Since the product is tolerant to moisture and saliva, it's used for fissure sealant of newly erupted teeth. Test 1 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.The tooth surface was rinsed with water and dried. Thereafter, Fuji® II LC was applied to the pits and fissures on the tooth surface using a brush. Then, the varnish was applied and cured according to the manufacturer's instructions.; Other Names: Fuji® II LC CAPSULE, GC Corporation, Tokyo, Japan; Device: Fuji Triage® CAPSULE; Fuji Triage® is a new generation glass ionomer containing with low viscosity, high fluoride content and light curing materials. Since the product is tolerant of moisture and saliva, it is used for fissure sealant of newly erupted teeth. Control newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.Then the tooth surface was rinsed with water and dried. Thereafter,Fuji Triage® was applied to the pits and fissures on the tooth surface using a brush. Thereafter, the varnish was applied and cured according to the manufacturer's instructions.; Other Names: Fuji Triage® CAPSULE, GC Corporation, Tokyo, Japan
Experimental: Group 2 (Clinpro XT Varnish-Fuji Triage); In Group 2, newly erupted mandibular permanent first molars were sealed with resin-modified glass ionomers containing fissure sealant material (Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USA) (test 2). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control).	Device: Fuji Triage® CAPSULE; Fuji Triage® is a new generation glass ionomer containing with low viscosity, high fluoride content and light curing materials. Since the product is tolerant of moisture and saliva, it is used for fissure sealant of newly erupted teeth. Control newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.Then the tooth surface was rinsed with water and dried. Thereafter,Fuji Triage® was applied to the pits and fissures on the tooth surface using a brush. Thereafter, the varnish was applied and cured according to the manufacturer's instructions.; Other Names: Fuji Triage® CAPSULE, GC Corporation, Tokyo, Japan; Device: Clinpro™ XT Varnish; Clinpro™ XT Varnish is a resin modified glass ionomer containing, fluoride-releasing, light-cured varnish. Since the product is tolerant to moisture and saliva, it is used for fissure sealant of newly erupted teeth. The product can be recharged with fluoride using fluoride-containing products. Test 2 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 35% phosphoric acid was applied to all surfaces of the tooth for 15 seconds.Then the tooth surface was rinsed with water and dried. Thereafter, Clinpro™ XT Varnish was applied in compliance with the manufacturers' instructions.; Other Names: Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USA
Experimental: Group 3 (Beautiful Flow- Fuji Triage); In Group 3, newly erupted mandibular permanent first molars were sealed with Giomer containing fissure sealant material (Beautifil Flow, Shofu, Kyoto, Japan) (test 3). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control).	Device: Fuji Triage® CAPSULE; Fuji Triage® is a new generation glass ionomer containing with low viscosity, high fluoride content and light curing materials. Since the product is tolerant of moisture and saliva, it is used for fissure sealant of newly erupted teeth. Control newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.Then the tooth surface was rinsed with water and dried. Thereafter,Fuji Triage® was applied to the pits and fissures on the tooth surface using a brush. Thereafter, the varnish was applied and cured according to the manufacturer's instructions.; Other Names: Fuji Triage® CAPSULE, GC Corporation, Tokyo, Japan; Device: Beautifil Flow; Beautiful Flow is a Giomer contained, fluoride releasing and light cured material. The product contains pre-reacted glass ionomer particles (PRG). It is a high water resistant material. It is used for fissure sealant. Test 3 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 7% phosphoric acid was applied to all surfaces of the tooth for 10 seconds. Then the tooth surface was rinsed with water and dried. Afterwards, a two-stage self-etch adhesive system was applied. Thereafter, Beautiful Flow was applied in compliance with the manufacturers' instructions.; Other Names: Beautifil Flow, Shofu, Kyoto, Japan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars.	The primary outcome of the study was the assessment of clinical retention rates at 18th months.	18 months after the clinical applications
The assessment of marginal adaptation rates of fissure sealants applied to newly erupted permanent first molars.	The primary outcome of the study was the assessment of marginal adaptation rates at 18th months.	18 months after the clinical applications
The assessment of marginal discoloration rates of fissure sealants applied to newly erupted permanent first molars.	The primary outcome of the study was the assessment of marginal discoloration rates at 18th months.	18 months after the clinical applications
The assessment of secondary caries rates of fissure sealants applied to newly erupted permanent first molars.	The primary outcome of the study was the assessment of secondary caries rates at 18th months.	18 months after the clinical applications

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The assessment of remineralization capacity using DIAGNOdent device	The secondary outcome of the study was the assessment of remineralization capacity using DIAGNOdent, at 18th months.	18 months after the clinical applications

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2019
• Primary Completion (Actual): November 16, 2020
• Study Completion (Actual): January 11, 2021

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 1, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: resin modified glass ionomer; Conventional glass ionomer; fissure sealant; giomer; laser fluorescence; newly erupted teeth
• Other Study ID Numbers: 2018-TDU-DİŞF-0050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No